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Cognitive Behavioral Treatments for Post-traumatic Stress Disorder (PTSD) Sleep Disturbance

Primary Purpose

Post-traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Imagery Rehearsal
Sleep and Nightmare Management
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-traumatic Stress Disorder focused on measuring Imagery, Nightmares, Post-Traumatic Stress Disorder, Psychotherapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male Vietnam Combat Veteran Diagnosis of combat-related PTSD Stable psychotropic regimen for a minimum of three months Experiences recurrent nightmares Exclusion Criteria: Bipolar disorder, delirium, dementia, amnestic and other cognitive disorders Schizophrenia and other psychotic disorders Substance abuse or dependence within the last six months Untreated medical disorders known to impact sleep

Sites / Locations

  • Philadelphia VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Imagery Rehearsal Therapy

Sleep and Nightmare Management

Outcomes

Primary Outcome Measures

Weekly Number of Nightmares
Weekly Nights With a Nightmare
Pittsburgh Sleep Quality Index
Total scores range from 0 to 21, with higher values indicating poorer sleep quality. A score greater than 5 distinguishes between poor and good sleepers.

Secondary Outcome Measures

Pittsburgh Sleep Quality Index - Addendum
The PSQI-A is a measure of PTSD-related sleep and dream disturbances. Scores can range from 0 to 21, with higher scores reflecting greater sleep problems.
Nightmare Effects Survey
This self-report questionnaire assesses psychosocial impairment attributed to nightmares. Eleven self-report questions are rated on a scale of zero to four. The individual scores are summed to produce a total score ranging from 0 to 44 (reported in the Table). Higher scores reflect greater impairment.
PTSD Military Checklist
Seventeen items indicating the 17 DSM-IV criteria for PTSD are rated on a 5-point scale, from 1 to 5. Scores range from 17 to 85, with a higher score indicating greater symptom severity.
Beck Depression Inventory
Twenty-one items are rated on a 4-point scale. Total scores range from zero to 63, with higher scores indicating more severe depression.
SF-36 Physical Component
The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 "worst"-100 "best").
SF-36 Mental Component
The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 5-8 primarily contribute to the mental component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 "worst"-100 "best").
Clinician-Administered PTSD Scale (CAPS)
Seventeen questions assess the frequency and intensity of PTSD symptoms. Scores range from zero to 136, with a higher score indicating more severe symptoms.

Full Information

First Posted
April 15, 2005
Last Updated
February 17, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00108628
Brief Title
Cognitive Behavioral Treatments for Post-traumatic Stress Disorder (PTSD) Sleep Disturbance
Official Title
7857 Cognitive - Behavioral Treatments for PTSD Sleep Disturbance
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the effectiveness of two cognitive behavioral group psychotherapy interventions in controlling the subjective sleep disturbance in veterans with Post-traumatic Stress Disorder.
Detailed Description
Repetitive, stereotypical nightmares and insomnia commonly characterize post-traumatic stress disorder (PTSD). Identifying the pathophysiological mechanisms of disrupted sleep in PTSD has therefore assumed considerable clinical importance. We previously reported an increase in rapid eye movement activity (REM activity) during REM sleep (REMS) in Vietnam War combat veterans with PTSD, and this finding can be seen as consistent with the view that most, although not all, dreaming occurs during REMS and the repeated observation that REM activity correlates with the intensity of dream mentation. There is a growing body of evidence that post-traumatic nightmares can respond to psychological treatment interventions. Namely, a cognitive-behavioral technique entitled imagery rehearsal (IR) has been reported to be effective in the treatment of such nightmares in victims of crime and in women who have been sexually assaulted. In a small pilot study, it has also been reported to be effective in the treatment of Vietnam veterans with combat-related PTSD. The two objectives of this proposal are: 1. To compare, in a study with random assignment and a parallel group design, the effectiveness in controlling the subjective sleep disturbance in veterans with PTSD of IR and Sleep and Nightmare Management (SN), a psychological treatment that targets life stressors and problems with sleep hygiene that may exacerbate insomnia and nightmares. 2. In a subset of these subjects, to compare the effectiveness in reducing REM activity of IR and SN.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder
Keywords
Imagery, Nightmares, Post-Traumatic Stress Disorder, Psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Imagery Rehearsal Therapy
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Sleep and Nightmare Management
Intervention Type
Behavioral
Intervention Name(s)
Imagery Rehearsal
Intervention Description
IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime.
Intervention Type
Behavioral
Intervention Name(s)
Sleep and Nightmare Management
Intervention Description
This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets
Primary Outcome Measure Information:
Title
Weekly Number of Nightmares
Time Frame
Baseline and 1, 3, and 6 months post-treatment
Title
Weekly Nights With a Nightmare
Time Frame
Baseline and 1, 3, and 6 months post-treatment
Title
Pittsburgh Sleep Quality Index
Description
Total scores range from 0 to 21, with higher values indicating poorer sleep quality. A score greater than 5 distinguishes between poor and good sleepers.
Time Frame
Baseline and 1, 3, and 6 months post-treatment
Secondary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index - Addendum
Description
The PSQI-A is a measure of PTSD-related sleep and dream disturbances. Scores can range from 0 to 21, with higher scores reflecting greater sleep problems.
Time Frame
Baseline and 1, 3, and 6 months post-treatment
Title
Nightmare Effects Survey
Description
This self-report questionnaire assesses psychosocial impairment attributed to nightmares. Eleven self-report questions are rated on a scale of zero to four. The individual scores are summed to produce a total score ranging from 0 to 44 (reported in the Table). Higher scores reflect greater impairment.
Time Frame
Baseline and 1, 3, and 6 months post-treatment
Title
PTSD Military Checklist
Description
Seventeen items indicating the 17 DSM-IV criteria for PTSD are rated on a 5-point scale, from 1 to 5. Scores range from 17 to 85, with a higher score indicating greater symptom severity.
Time Frame
Baseline and 1, 3, and 6 months post-treatment
Title
Beck Depression Inventory
Description
Twenty-one items are rated on a 4-point scale. Total scores range from zero to 63, with higher scores indicating more severe depression.
Time Frame
Baseline and 1, 3, and 6 months post-treatment
Title
SF-36 Physical Component
Description
The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 "worst"-100 "best").
Time Frame
Baseline and 1, 3, and 6 months post-treatment
Title
SF-36 Mental Component
Description
The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 5-8 primarily contribute to the mental component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 "worst"-100 "best").
Time Frame
Baseline and 1, 3, and 6 months post-treatment
Title
Clinician-Administered PTSD Scale (CAPS)
Description
Seventeen questions assess the frequency and intensity of PTSD symptoms. Scores range from zero to 136, with a higher score indicating more severe symptoms.
Time Frame
Baseline and 1 month post-treatment

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male Vietnam Combat Veteran Diagnosis of combat-related PTSD Stable psychotropic regimen for a minimum of three months Experiences recurrent nightmares Exclusion Criteria: Bipolar disorder, delirium, dementia, amnestic and other cognitive disorders Schizophrenia and other psychotic disorders Substance abuse or dependence within the last six months Untreated medical disorders known to impact sleep
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard J. Ross, MD PhD
Organizational Affiliation
Corporal Michael J. Crescenz VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philadelphia VA Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23047646
Citation
Harb GC, Thompson R, Ross RJ, Cook JM. Combat-related PTSD nightmares and imagery rehearsal: nightmare characteristics and relation to treatment outcome. J Trauma Stress. 2012 Oct;25(5):511-8. doi: 10.1002/jts.21748. Epub 2012 Oct 9.
Results Reference
result
PubMed Identifier
20839311
Citation
Cook JM, Harb GC, Gehrman PR, Cary MS, Gamble GM, Forbes D, Ross RJ. Imagery rehearsal for posttraumatic nightmares: a randomized controlled trial. J Trauma Stress. 2010 Oct;23(5):553-63. doi: 10.1002/jts.20569.
Results Reference
result
Citation
Cook JM, Thompson R, Harb GC, Ross RJ. Cognitive-behavioral treatment for posttraumatic nightmares: An investigation of predictors of dropout and outcome. Psychological trauma : theory, research, practice and policy. 2013 Nov 1; 5(6):545-553.
Results Reference
result

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Cognitive Behavioral Treatments for Post-traumatic Stress Disorder (PTSD) Sleep Disturbance

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